SPL v2
SPL
SPL Set ID f2b6c157-1af1-8d43-e053-2995a90aaf1a
Route
ORAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Anhydrous Lactose Starch, Corn Polyethylene Glycol, Unspecified Lactose Monohydrate Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SG;202 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Completed Since 2022-11-16 Until 2026-10-28

Description

Fexofenadine HCL 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCL 180 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Directions
 adults and children 12 years of age and over  take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
 children under 12 years of age  do not use
 adults 65 years of age and older  ask a doctor
 consumers with kidney disease  ask a doctor
Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information
  • each tablet contain: sodium 8 mg
  • store between 20 to 25°C (68 to 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions Or Comments?

Call: 1-800-616-2471

Principal Display Panel

 COMPARE TO the active ingredient in ALLEGRA® ALLERGY 24 HOUR*

FEXOFENADINE HYDROCHLORIDE USP 180 mg

 Antihistamine

ALLERGY RELIEF

24-HOUR Relief of:

  • sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Indoor and Outdoor

Allergy Relief

Non-Drowsy

Capsule Shaped Tablets

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

When Using This Product
  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each film Coated tablet)

Fexofenadine HCL 180 mg


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Purpose

Antihistamine

Directions
 adults and children 12 years of age and over  take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
 children under 12 years of age  do not use
 adults 65 years of age and older  ask a doctor
 consumers with kidney disease  ask a doctor
Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information (Other information)
  • each tablet contain: sodium 8 mg
  • store between 20 to 25°C (68 to 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions Or Comments? (Questions or comments?)

Call: 1-800-616-2471

Principal Display Panel

 COMPARE TO the active ingredient in ALLEGRA® ALLERGY 24 HOUR*

FEXOFENADINE HYDROCHLORIDE USP 180 mg

 Antihistamine

ALLERGY RELIEF

24-HOUR Relief of:

  • sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Indoor and Outdoor

Allergy Relief

Non-Drowsy

Capsule Shaped Tablets

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

When Using This Product (When using this product)
  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each film Coated tablet) (Active ingredient (in each film-coated tablet))

Fexofenadine HCL 180 mg


Advanced Ingredient Data


Raw Label Data

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